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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number CAR-170-C
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Anxiety (2328)
Event Date 11/26/2019
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions.
 
Event Description
A report was received on 26 nov 2019 from a home therapy nurse (htn) regarding a (b)(6) year old male with a medical history of end-stage renal disease and hypertension, stating the patient experienced a hypersensitivity type reaction during hemodialysis treatment on (b)(6) 2019. Additional information was received (b)(6) 2019 from the htn stating symptoms developed within 5 minutes of initiating treatment and included shortness of breath, facial swelling, and feeling anxious. Treatment was terminated without rinseback and the patient was transported to hospital, evaluated in the emergency room, given 0. 5mg epinephrine and dialysis treatment. The patient recovered without sequelae and was released same day to continue therapy using the nxstage system one.
 
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Brand NameNXSTAGE SYSTEM ONE
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
Manufacturer (Section G)
MEDIMEXICO S. DE R. L. DE C. V
av. valle imperial no. 10523
parque industrial valle sur
tijuana 22180
MX 22180
Manufacturer Contact
paula rogalski
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key9475442
MDR Text Key183105227
Report Number3003464075-2019-00078
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2021
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number90877015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/16/2019 Patient Sequence Number: 1
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